MAUDE Adverse Event Report: Nuvasive, Inc. ReLine; Pedicle screw spinal system, adolescent idiopathic scoliosis

Model Number	13046030
Medical Device Problem Codes	Fracture (1260); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received for evaluation.The root cause cannot be determined at this time.A supplemental report will be submitted upon receipt of additional information.
Event or Problem Description
It was reported that the uni screw threads sheared off and we were not able to final tighten.We used the reline peds towers along with the pile drivers for reduction.Two screws were at the top of the construct, and one was in the middle.Removed rod and replaced screws.

• Brand Name: ReLine
• Common Device Name: Pedicle screw spinal system, adolescent idiopathic scoliosis
• Manufacturer (Section D): Nuvasive, Inc.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): Globus Medical, Inc.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; +1(610)930-1800
• MDR Report Key: 24364137
• Report Number: 2031966-2026-00025
• Device Sequence Number: 15820469
• Product Code: OSH
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 13046030
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown